# US 10,500,043 B2 · Alignment of an implantable medical device

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- Number: US 10,500,043 B2
- Document ID: US10500043B2
- Status: Granted
- Kind: B2
- Application number: 15/400,210
- Filed: 2017-01-06
- Published: 2017-04-27
- Granted: 2019-12-10
- Earliest claimed: 2013-09-12
- Assignees: St. Jude Medical, Cardiology Division, Inc.
- Applicants: St. Jude Medical, Cardiology Division, Inc.
- Inventors: Gary W. Geiger; Aaron J. Chalekian
- Web page: https://patentgrep.com/patent/US10500043B2

## CPC

- A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation}
- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- A61F 2/2433: {using balloon catheter}
- A61F 2/2436: {Deployment by retracting a sheath}
- A61F 2/2439: {Expansion controlled by filaments}
- A61M 25/0147: {with movable mechanical means, e.g. pull wires}
- A61M 25/02: Holding devices, e.g. on the body
- A61B 2017/3484: {Anchoring means, e.g. spreading-out umbrella-like structure}
- A61F 2/962: having an outer sleeve
- A61F 2/966: with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
- A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol
- A61F 2220/0025: Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61M 2025/0293: {Catheter, guide wire or the like with means for holding, centering, anchoring or frictionally engaging the device within an artificial lumen, e.g. tube}
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A medical device delivery system includes an inner shaft having a proximal end and a distal end, a support shaft having a proximal end and a distal end and an articulating assembly disposed between the inner shaft and the support shaft. The support shaft is sized for insertion into the circulatory system of a patient. The articulating assembly includes a first portion extending from the distal end of the inner shaft and a second portion at the proximal end of the support shaft. The first portion is pivotable relative to the second portion to change orientation of the support shaft relative to the inner shaft. A retainer is secured to a portion of the articulating assembly and is configured to retain a medical device on the support shaft between the retainer and the distal end of the support shaft.

## Claims

### Claim 1

A medical device delivery system, comprising:
an inner shaft having a proximal end and a distal end;
a support shaft having a proximal end, a distal end and a distal tip at the distal end, the support shaft being sized for insertion into the circulatory system of a patient;
an articulating assembly disposed between the inner shaft and the support shaft, the articulating assembly including a first portion extending from the distal end of the inner shaft and a second portion at the proximal end of the support shaft, the first portion being pivotable relative to the second portion to change the orientation of the support shaft relative to the inner shaft, and
a retainer secured to the second portion of the articulating assembly,
wherein the support shaft extends distally from the retainer to the distal tip so as to support a medical device thereupon between the retainer and the distal tip.

### Claim 2 (depends on 1)

The delivery system of claim 1, wherein the articulating assembly includes a plurality of control wires, movement of one of the control wires proximally causing the second portion of the articulating assembly to pivot relative to the first portion of the articulating assembly.

### Claim 3 (depends on 2)

The delivery system of claim 2, wherein one of the first and second portions of the articulating assembly is a ball and another of the first and second portions of the articulating assembly is a socket sized to pivotably receive the ball.

### Claim 4 (depends on 2)

The delivery system of claim 2, wherein the plurality of control wires includes four control wires secured to the second portion of the articulating assembly.

### Claim 5 (depends on 4)

The delivery system of claim 4, wherein a first two of the control wires lies in a first plane and a second two of the control wires lies in a second plane perpendicular to the first plane.

### Claim 6 (depends on 2)

The delivery system of claim 2, further comprising:
a handle disposed proximally of the inner shaft; and
an actuator assembly secured to the handle, the actuator assembly including a housing pivotably mounted to the handle, the plurality of control wires being secured to the housing so that a pivoting movement of the housing relative to the handle pulls at least one of the control wires proximally.

### Claim 7 (depends on 6)

The delivery system of claim 6, further comprising an anchor for securing the plurality of control wires.

### Claim 8 (depends on 7)

The delivery system of claim 7, further comprising a wedge mounted within the anchor for securing the plurality of control wires.

### Claim 9 (depends on 8)

The delivery system of claim 8, wherein the wedge comprises a frustoconical body and the anchor includes a slot configured for accommodating the wedge.

### Claim 10 (depends on 1)

The delivery system of claim 1, further comprising a distal outer sheath configured to cover the inner shaft and the support shaft in a first condition, and movable to a second condition exposing the support shaft; and
a proximal outer sheath configured to cover the inner shaft.

### Claim 11 (depends on 10)

The delivery system of claim 10, further comprising a constricting element mounted on the inner shaft and comprising a generally cylindrical portion and an outwardly flaring portion facing the articulating assembly.

### Claim 12 (depends on 11)

The delivery system of claim 11, wherein the outwardly flaring portion has a diameter greater than a diameter of the proximal outer sheath.

### Claim 13 (depends on 1)

The delivery system of claim 1, wherein the inner shaft includes a plurality of notches proximal to the distal end.

### Claim 14 (depends on 1)

The delivery system of claim 1, wherein one of the first and second portions of the articulating assembly includes a generally concave bearing surface and another of the first and second portions of the articulating assembly includes a ball pivotably engaging the bearing surface,
the delivery system further including a sheath covering the first and second portions of the articulating assembly and longitudinally constraining the ball relative to the bearing surface.

### Claim 15 (depends on 1)

The delivery system of claim 1, wherein the support shaft has a first diameter and the retainer has a second diameter greater than the first diameter.

### Claim 16

A medical device delivery system, comprising:
a support shaft having a proximal end, a distal end and a conically shaped distal tip at the distal end;
an inner shaft having a proximal end and a distal end;
an articulating assembly disposed between the support shaft and the inner shaft;
a retainer secured to a portion of the articulating assembly, wherein the support shaft extends distally from the retainer to the conically shaped distal tip so as to support a medical device in a collapsed condition thereupon between the retainer and the conically shaped distal tip;
a handle disposed proximally of the inner shaft;
an actuator mechanism pivotably secured to the handle; and
a plurality of control wires operatively interconnecting the articulating assembly and the actuator mechanism such that pivoting movement of the actuator mechanism causes a corresponding pivoting movement of the support shaft relative to the inner shaft.

### Claim 17 (depends on 16)

The delivery system of claim 16, wherein the articulating assembly includes a ball pivotably engaged in a socket.

### Claim 18 (depends on 17)

The delivery system of claim 17, wherein the ball is at the distal end of the inner shaft and the socket is at the proximal end of the support shaft.

### Claim 19 (depends on 18)

The delivery system of claim 18, wherein the plurality of control wires have first ends secured to the socket.

### Claim 20 (depends on 16)

The delivery system of claim 16, further comprising a distal outer sheath and a proximal outer sheath for covering the inner shaft, the articulating assembly and the support shaft.
